Gender Solutions® Natural-Knee® Prolong® 00-5420-008-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024189584), received between Jun 18, 2024 and Nov 27, 2024 — classified as 3 injuries.

73 other recalls cover devices cleared under the same FDA submission (K070214, K071107, K073286, K173057, K972774); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY AND APPROXIMATELY 3 MONTHS POST-OP, THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDONITIS AND RECEIVED A STEROID INJECTION. THE PATIENT CONTINUED TO HAVE ONGOING ISSUES WITH PAIN, SWELLING, QUADRICEP WEAKNESS/ATROPHY, BALANCE DEFICITS, AND LIMITED RANGE OF MOTION. ADDITIONAL COURSES OF PHYSICAL THERAPY WERE PRESCRIBED WITHOUT RESOLUTION. THE PATIENT DOES NOT WANT TO UNDERGO ANOTHER REVISION AND HAS CONTINUED TO SEEK HELP FOR ONGOING SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Electrolyte Imbalance; Inflammation; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20796436 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR POST-OP, THE PATIENT WAS EXPERIENCED ONGOING QUADRICEP MUSCLE WEAKNESS AND ATROPHY, PAIN, STIFFNESS, LIMITED RANGE OF MOTION, AND INSTABILITY. THE PATIENT UNDERWENT ADDITIONAL COURSES OF PHYSICAL THERAPY WITHOUT RELIEF. SUBSEQUENTLY, THE PATIENT WAS REVISED. THE INTRA-OP TISSUE SAMPLE DISPLAYED FIBROCONNECTIVE TISSUE AND REACTIVE SYNOVIUM WITH FIBROSIS. ALL COMPONENTS WERE REVISED EXCEPT THE PATELLA. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Joint Laxity; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19575464 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY AND APPROXIMATELY 3 MONTHS POST-OP, THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDONITIS AND RECEIVED A STEROID INJECTION. THE PATIENT CONTINUED TO HAVE ONGOING ISSUES WITH PAIN, SWELLING, QUADRICEP WEAKNESS/ATROPHY, BALANCE DEFICITS, AND LIMITED RANGE OF MOTION. ADDITIONAL COURSES OF PHYSICAL THERAPY WERE PRESCRIBED WITHOUT RESOLUTION. THE PATIENT DOES NOT WANT TO UNDERGO ANOTHER REVISION AND HAS CONTINUED TO SEEK HELP FOR ONGOING SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Electrolyte Imbalance; Inflammation; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19563262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070214, K071107, K073286, K173057, K972774. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1061-2018 · Nov 29, 2017 · Terminated
  GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT
• Z-1060-2018 · Nov 29, 2017 · Terminated
  GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM
• Z-1058-2018 · Nov 29, 2017 · Terminated
  CR-FLEX GSF PCT SZ C-R MINUS CR-FLEX GSF PCT SZ D-L MINUS CR-FLEX GSF PCT SZ D-R MINUS CR-FLEX GSF PCT SZ E-L MINUS CR-FLEX GSF PCT SZ E-R MINUS CR-FLEX GSF PCT SZ F-L MINUS CR-FLE
• Z-1059-2018 · Nov 29, 2017 · Terminated
  CR-FLEX GSF PRECOAT SZ C-L CR-FLEX GSF PRECOAT SZ C-R CR-FLEX GSF PRECOAT SZ D-L CR-FLEX GSF PRECOAT SZ D-R CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R CR-FLEX GSF PRECOA
• Z-0838-2016 · Jan 11, 2016 · Terminated
  CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constraine
• Z-2584-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing i
• Z-2583-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing
• Z-2585-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is
• Z-2582-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is
• Z-1248-2014 · Feb 25, 2014 · Terminated
  Gender Solutions" Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
• Z-0237-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Wars
• Z-0205-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; R
• Z-0248-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, W

…and 58 more.